Date:22/12/2004 URL: http://www.thehindubusinessline.com/2004/12/22/stories/2004122201650200.htm

Back Ranbaxy gets FDA nod for hypertension drug

Our Bureau

New Delhi , Dec. 21

RANBAXY Laboratories Ltd has received approval from the US Food and Drug Administration (FDA) to manufacture and market Fosinopril Sodium and Hydrochlorothiazide tablets for the treatment of hypertension.

Ranbaxy's formulation was found to be bio-equivalent and with the same therapeutic effect as that of the reference-listed drug Monopril-HCT of Bristol-Myers Squibb. The total market sales for Monopril-HCT stood at $24.2 million.

"This final approval will allow Ranbaxy to offer the complete line of generic product formulations of Fosinopril to our customers and reflects our continued effort and commitment to supply affordable generic products to the market. The product will be made available immediately," said Mr Jim Meehan, Vice-President of Sales and Marketing for RPI, USA.